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Delivering complex and innovative trials

The clinical research landscape is changing and clinical trials are evolving to find new, faster and more efficient ways to bring new treatments to patients.

The NIHR has been supporting the delivery of novel, complex and innovative clinical trials over the last decade. Find out how we can support you to plan, set up and deliver your trial or study to time and target in the UK.

Complex clinical trial designs (methodologies) and innovative approaches to recruitment and delivery have the potential to improve the speed and efficiency of clinical trials, shorten drug development timelines and, ultimately, bring new treatments to patients faster. Developments in science and technology also mean that innovative clinical trials are needed to assess new medicines in different (often smaller, more specific) patient populations.  

The NIHR is responding to this evolution and on this page you can discover how we are supporting the next generation of clinical trials. 

Through case study content you will find out how we are advocating the adoption of the adaptive trial model, helping to realise the value of register-facilitated research, and promoting the benefits of the platform approach, to name just a few.

The phrase ‘complex and innovative trial design’ includes, but extends further than the trial methodology or design. The complexity may also exist in the set-up,  recruitment, delivery or the statistical analysis and mathematics which underpin the trial. The term should be used in its broadest sense, and not be limited to specific trial designs.

Any trial design that differs from the standard randomised controlled trial (RCT) design and delivers results more efficiently, reduces the study timeline, and maximises the knowledge gained could be described as novel or innovative.

Common examples of methodologies that are considered complex and/or innovative include:

  • Adaptive (umbrella, basket, adaptive, platform, dose-ranging)
  • Targeted or stratified 
  • Real-world
  • Bayesian

The following case studies illustrate how the NIHR has been supporting some of these approaches.

When we talk about ‘innovative delivery’ we are focusing on the set-up and the delivery of the trial, as opposed to the design. The design may be simple or standard, but the way it is delivered may be more streamlined, efficient, quicker or more patient-friendly than what has been done before. The term should be used in its broadest sense for all approaches that present an innovative solution to trial delivery.  For example, this includes research that is conducted using:

  • electronic patient records and data linkages
  • research registries and biorepositories
  • digital tools for electronic patient reported outcomes (ePROMs)
  • streamlining processes across sites 
  • risk adaptation (e.g. virtual monitoring, proportionate Source Data Verification SDV)
  • proportionate consent (e.g. cluster randomisation, emergency settings) 
  • virtual and/or siteless trials
  • health services research and public health research

The list is not exhaustive and other approaches, such as patient-led trials, also fall into this category.

The following case studies illustrate how the NIHR has been supporting some of these approaches.

The NIHR is evolving the UK’s research infrastructure to support innovative clinical trials. One of our priorities is to ensure that the NHS workforce has the knowledge and skills required to deliver the next generation of clinical trials.

A new eLearning resource which is freely available to all NHS and NIHR staff (and other organisations on request) via NIHR Learn.

Below you will find some videos which provide a taster of this new learning resource.
















Latest casestudies

An adaptive dose-ranging trial of telmisartan in HIV patients

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Rococo: Real-world research in a pharmacy setting

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Complex and innovative trial design and delivery case study and podcast library

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